Apparatus and display methods relating to intravascular placement of a catheter

• US 8,849,382 B2
• Filed: 09/10/2009
• Issued: 09/30/2014
• Est. Priority Date: 11/26/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Cox, Jeremy B., Crook, Christian W., Misener, Anthony K., Morgan, Paul D., Morris, Daniel R.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US12/557,401
• Publication Number:
  US 20100036227A1
• Time in Patent Office: 1,846 Days
• Field of Search: 600/509, 607/116, 607/119, 607/122
• US Class Current: 600/509
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An integrated catheter placement system for accurately placing a catheter within a patient'"'"'s vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient'"'"'s chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient'"'"'s heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Claims

1. A catheter placement system for inserting a catheter into a vasculature of a patient, comprising:

a catheter assembly including;

a catheter, a distal end of the catheter comprising a conductive band; and

a stylet removably received within a lumen of the catheter comprising an ECG sensor component for detecting ECG signals of a node of a heart of the patient when at least a portion of the catheter assembly is disposed within the vasculature of the patient, the stylet including two conductive portions longitudinally separated by an interposed nonconductive portion, wherein the nonconductive portion has a longitudinal length less than a longitudinal length of the conductive band;

an ECG signal receiving component that receives ECG signals detected by the ECG sensor component, the ECG signal receiving component being operably connectable to the ECG sensor component; and

a connection integrity component that verifies an integrity of an operable connection between the ECG signal receiving component and the ECG sensor component.

2. The catheter placement system as defined in claim 1, further comprising at least one ECG electrode for placement on a skin portion of the patient wherein the ECG signal receiving component is disposed external to the patient.

3. The catheter placement system as defined in claim 2, wherein the at least one external ECG electrode includes a first electrode and a second electrode positioned on a single pad for placement on the skin portion of the patient.

4. The catheter placement system as defined in claim 2, wherein the connection integrity component verifies that the external ECG electrode is operably connected to the skin portion of the patient and that the ECG sensor component of the stylet is operably connected to the ECG signal receiving component.

5. The catheter placement system as defined in claim 4, wherein the connection integrity component applies a first voltage to the ECG sensor component of the stylet and a second voltage different from the first voltage to the external ECG electrode.

6. The catheter placement system as defined in claim 5, further comprising a second external ECG electrode for placement on a skin portion of the patient, and the connection integrity component monitors a resulting voltage to determine whether the external ECG electrode and the second external ECG electrode are properly connected to the skin portion of the patient.

7. The catheter placement system as defined in claim 6, wherein the resulting voltage monitored by the connection integrity component comprises a detected signal from the second external ECG electrode and an average voltage from the first and second voltage.

8. The catheter placement system as defined in claim 2, wherein the connection integrity component comprises a radiating element configured to emit a signal of a known frequency.

9. The catheter placement system as defined in claim 8, wherein the connection integrity component is configured to detect a radiating signal present on the ECG sensor component of the stylet and the external ECG electrode generated from the signal of known frequency from the radiating element disposed external to the patient.

10. The catheter placement system as defined in claim 9, wherein the connection integrity component is configured to compare the radiating signal with a threshold, and determine that the operable connection is closed if the radiating signal is below the threshold.

11. The catheter placement system as defined in claim 2, wherein the connection integrity component is configured to detect a radiating signal present on the ECG sensor component of the stylet and the external ECG electrode generated from a natural signal line noise naturally present on the electrode of the stylet and the external ECG electrode.

12. The catheter placement system as defined in claim 2, wherein a distal end of the stylet comprises a conductive wire loop to form a closed circuit when the stylet is operably connected to the ECG signal receiving component.

13. The catheter placement system as defined in claim 12, wherein the connection integrity component tests a continuity circuit created by the conductive wire loop to check the continuity of the distal end of the stylet.

14. The catheter placement system as defined in claim 13, wherein the conductive wire loop has a bias toward a bent configuration.

15. The catheter placement system as defined in claim 13, wherein at least a portion of the continuity circuit of the conductive wire loop comprises a planar wire.

16. The catheter placement system as defined in claim 2, wherein the at least one external ECG electrode includes an image, wherein the image indicates proper placement of the at least one external ECG electrode on the skin portion of the patient.

17. The catheter placement system as defined in claim 1, further comprising a display and an indicator icon included on the display, wherein the indicator icon indicates a status of the operable connection between the ECG signal receiving component and the ECG sensor component.

18. The catheter placement system as defined in claim 1, wherein the ECG signal receiving component is operably connectable to the ECG sensor component via a physical connection therebetween.

19. The catheter placement system as defined in claim 18, wherein the connection integrity component includes at least one of an impedance-based sensing circuit, an inductive sensing circuit, a capacitive sensing circuit, and a voltage-based circuit.

20. The catheter placement system as defined in claim 1, the stylet including an assembly for detecting if the stylet has been severed.

21. The catheter placement system as defined in claim 1, the stylet including a system for ensuring a distal end of the stylet is substantially aligned with a distal end of the catheter.

22. The catheter placement system as defined in claim 1, further comprising a footswitch for controlling an aspect of the catheter placement system functionality during use.

23. The catheter placement system as defined in claim 1, wherein the connection integrity component includes a radiating element for emitting a signal detectable on at least one lead wire of the ECG sensor component.

24. The catheter placement system as defined in claim 1, wherein the connection integrity component can verify the operable connection prior to inserting the catheter assembly into the vasculature of the patient.

25. The catheter placement system as defined in claim 1, wherein the connection integrity component comprises a voltage balanced-based system to determine the connectivity of the ECG sensor component to the ECG signal receiving component.

26. The catheter placement system as defined in claim 1, further comprising a first external electrode and a second external electrode, both operably connectable to the ECG sensor component, wherein the ECG sensor component comprises a first connector and the ECG signal receiving component comprises a second connector configured to create the operable connection between the ECG sensor component and the ECG signal receiving component when the first connector and second connector are joined, and wherein the connection integrity component is configured to verify an integrity of a connection to a skin portion of the patient by the first external electrode and the second external electrode and to verify the integrity of the operable connection created between the first and second connector.